CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL

CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL is an FDA 510(k)-cleared medical device (K802142) manufactured by American Dade. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 9, 1980. Regulation: 8.